Status:
UNKNOWN
A Study Evaluating the Safety and Efficacy of Cura-100 in Subjects With Rheumatoid Arthritis and Osteoarthritis
Lead Sponsor:
Cura Biotech LLC
Conditions:
Rheumatoid Arthritis
Osteoarthritis
Eligibility:
All Genders
20-50 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of the study is to evaluate the safety and efficacy of Cura-100 in treating rheumatoid arthritis and osteoarthritis.
Detailed Description
This is the Phase I/II trial, which monitors both safety and efficacy of Cura-100 in subjects with rheumatoid arthritis and osteoarthritis at one clinical study center. The open-label clinical study w...
Eligibility Criteria
Inclusion
- Having a diagnosis of rheumatoid arthritis and osteoarthritis at active stage
- Able and willing to comply with study visits and procedures specified in this protocol for at least six months period
- Able to understand and willing to sign and date the written informed consent form prior to admission of the study
- Able and willing to provide adequate information for locator purposes
- Able and willing to provide self evaluation information and diagnostic report of arthritis as required for efficacy evaluation
Exclusion
- Pregnant women
- Over-weighted
- Hypertension, or diabetes, or a history of cardiovascular disease or kidney disease, or serious skin allergy or other concurrent clinically significant illness or medical condition (other than arthritis) which, in the viewpoint of the study doctor, may put the subject at a possible risk for participation
- Patients used biologic modifier therapy or currently taking immunosuppressive agents might be excluded
- Unable to spend 3 hours for treatment at the study center
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2008
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00455208
Start Date
May 1 2007
End Date
December 1 2008
Last Update
February 19 2009
Active Locations (1)
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1
Cura Biotech LLC
Sunnyvale, California, United States, 94087